(Updated - January 22, 2024 12:43 PM EST)
Investing.com -- Gilead Sciences (NASDAQ:GILD) has announced that a late-stage trial of its antibody-drug conjugate Trodelvy failed to significantly improve survival in patients suffering from a certain type of lung cancer, sending shares down by their most since 2015 on Monday.
As of 12:42 EDT (17:42 GMT), GILD was down 10.7%.
In a statement, California-based Gilead said that the Phase 3 EVOKE-01 study of the prescription medicine did not meet the primary endpoint of overall survival in patients with advanced or metastatic non-small cell lung cancer (NSCLC) that previously received platinum-based chemotherapy or a checkpoint inhibitor.
The trial aimed to evaluate Trodelvy versus docetaxel, a type of chemotherapy medication. There was a more than three-month difference in median overall survival favoring Trodelvy seen in about 60% of the trial population with both squamous and non-squamous lung cancer, Gilead said.
However, analysts at Jefferies noted that this "may not be enough to matter or to file to [the Federal Drug Administration, the U.S. drug regulator]."
Gilead added that it intends to share its results from the second-line trial of 603 patients with regulators and later present the findings at an upcoming medical meeting.
"Treating metastatic NSCLC that has progressed on or after platinum-based chemotherapy presents significant challenges and the need for safe and effective treatments remains urgent," said Gilead Chief Medical Officer Merdad Parsey.
Trodelvy, which Gilead said has shown "meaningful survival advantages" in two types of breast cancer and improved clinical outcomes for certain people with bladder cancer, has not received regulatory approval for the treatment of metastatic NSCLC -- the most common type of lung cancer.
On the other hand, analysts at Evercore ISI noted that the stock was "overreacting" to the news.
"Technically, this was a high risk trial after AZN’s similar Trop2 ADC drug also missed in this lung setting. For that reason, I don’t think reaction should be this hard. - However, I do acknowledge, that GILD was well owned into the new year," they said.
"The reason to like GILD is that it’s a long-term growth story … driven by HIV (not oncology) – and that remains fully intact. In that vein, and knowing that AZN trial had already cast doubts on this GILD study, I think -10% is an overreaction."
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Additional reporting by Lon Juricic